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Manufacturers Use Recent Study to Claim Xarelto is Safe

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Over 1,900 Xarelto lawsuits are currently pending in state and federal courts, with plaintiffs claiming that the anticoagulant caused serious injuries, including gastrointestinal bleeding, blood clots, stroke, and heart attack.

Within just a couple years of being on the market, Xarelto (rivaroxaban) was associated with nearly 700 adverse events, as reported in the Institute of Safe Medicine Practices’ QuarterWatch. Now, however, Xarelto manufacturers Janssen Pharmaceuticals and Bayer AG are claiming that their product is safe, and that the results of a recent study support their assertions that bleeding rates are low in patients taking the drugs.

Defendant Claims Studies Show Low Risk of Bleeding with Xarelto

According to a press release issued by Johnson & Johnson (parent company of Janssen Pharmaceuticals), the results of the PMSS (Post-Marketing Safety Surveillance) and XANTUS (Xarelto for Prevention of Stroke in Patients with Atrial Fibrillation) studies showed “rates and patterns of major bleeding in routine clinical practice were low (2.89 and 2.1 per 100 person years, respectively), and generally consistent with those observed in Phase 3 clinical research.”

According to the drug company, the studies included more than 45,000 patients, and were meant to confirm the safety of Xarelto in “real-world settings.”

The PMSS study is an ongoing, five-year study evaluating U.S. patients who take the once-daily Xarelto for non-valvular atrial fibrillation. The FDA approved Xarelto in 2011, to help reduce the risk of blood clots and stroke in patients with non-valvular atrial fibrillation. The most common bleeding events found in the study included gastrointestinal and intracranial.

The XANTUS study reviewed data from patients taking once-daily Xarelto for stroke prevention in Europe, Canada, and Israel, and involved nearly 6,800 patients.

Other Studies Show Conflicting Results

Though the manufacturers would like the public to believe that these studies are the final word on the matter, questions remain, especially as other studies have found conflicting results, which highlight the potential dangers associated with Xarelto. In 2015, for example, researchers compared rivaroxaban with dabigatran (Pradaxa), another newer generation anticoagulant, and warfarin, the leading blood thinner for decades.

Though results showed similar bleeding rates, the researchers noted: “Although rates of gastrointestinal bleeding seem to be similar in this commercially insured sample of adults in the United States, we cannot rule out as much as a…twofold higher risk of bleeding with rivaroxaban [Xarelto] compared with warfarin.”

An earlier 2013 study also found that patients given newer-generation anticoagulants, like Xarelto, had an increased risk of gastrointestinal bleeding over patients who received standard care. In addition, a 2014 study noted that treatment with rivaroxaban could be associated with severe liver injury.

Plaintiffs Claim Xarelto Manufacturers Failed to Warn About Serious Side Effects

Despite this recent study that defendants have relied on to claim that Xarelto is safe, plaintiffs proceeding in Xarelto lawsuits claim the manufacturers didn’t do enough to warn doctors and patients about the serious side effects of the drug, including its potential to cause serious and potentially life-threatening internal bleeding. In response to the growing litigation, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federally filed lawsuits into the Eastern District of Louisiana in December 2014. Over 1,600 cases are now pending there, with another over 300 proceeding in a mass tort in Pennsylvania.